Ukraine. Pharmaceutical Market Access and Regulations
Key Issues of Concern:
Intellectual property protections: PhRMA‘s member companies are highly concerned by the non-transparent introduction of a regulatory initiative (Resolution of the Cabinet of Ministers of Ukraine No. 877 dated December 4, 2013) aiming to implement a compulsory licensing mechanism for pharmaceutical products.
Price regulation measures: Reference pricing mechanisms that the Ukrainian Government is implementing in pilot projects on state regulation of prices for antihypertension and insulin medicinal products create direct preferences for locally produced drugs and market barriers for imported products.
Import licensing law: In a positive development, some of the most concerning aspects of Law No. 5038-VI ―On Import Licensing for Medicinal Products‖ (July 4, 2012) and the Import Licensing Conditions (established by Ministry of Health Order No. 453 dated May 30, 2013), were postponed by Ministerial Order No. 960 (November 11, 2013) until March 2016. Nonetheless, implementation of the Import Licensing Conditions will need to be monitored closely to ensure that they do not discriminate against foreign manufacturers.
Transparency: Regulations and laws are being adopted without adequate transparency and with little opportunity for PhRMA members to provide substantive input.
For these reasons, PhRMA requests that Ukraine be placed on the Priority Watch List for the 2014 Special 301 Report, and that the U.S. Government continue to seek assurances that the problems described herein are quickly and effectively resolved.
Intellectual Property Protections
Compulsory Licensing Resolution
On December 4, 2013, the Cabinet of Ministers adopted Resolution No. 877 ―On Approval of the Procedure for Granting Authorization to Use an Object of Intellectual Property Regarding a Medicinal Product by the Cabinet of Ministers of Ukraine‖ (―the Resolution‖). With great assistance from the U.S. Embassy to Ukraine, representatives of the research-based pharmaceutical industry were finally included in the process in 2013.Nonetheless, despite several amendments to a draft of the Resolution, the contours of the proposed compulsory licensing mechanism remain vague. Some of the innovative biopharmaceutical industry‘s proposals expressed during the discussion of the drafts with the Ministry of Health have been taken into account in the adoption of the final Resolution. However, essential problems and issues still have not been resolved and remain in the final adopted Resolution. PhRMA and its member companies are highly concerned that Ukraine could issue compulsory licenses in order to support the commercial interests of specific local companies to the detriment of U.S. manufacturers of innovative pharmaceuticals.
Market access barriers
Price regulation measures
In May 2013 the Cabinet of Ministers of Ukraine amended Resolution No. 340 (dated April 25, 2012) (―A Pilot Project on state price regulation for anti-hypertensive medicines‖), thereby excluding most imported anti-hypertensive medicines from Ukraine‘s reimbursement lists.On August 14, 2013, the Cabinet of Ministers launched another Pilot Project on state price regulation for insulin products (CMU Resolution No. 732, amended by CMU Resolution No. 952 on December 25, 2013). The reference pricing methodology proposed by the Ministry of Health (MoH) will challenge the ability of PhRMA‘s members to continue to sell insulin in the Ukraine, thereby resulting in less and potentially substandard treatment options for Ukrainian patients. Furthermore, there are administrative barriers for Ukrainian patients with diabetes to access the modern therapy, which are established by two Ministerial Orders (No. 160 dated March 23, 2011 and No. 618 dated July 18, 2013).
Import Licensing
The Law ― On amending certain Laws of Ukraine with regard to licensing imports of medicinal products and defining the term ― Active Pharmaceutical Ingredient (API)‖ (No. 5038-VI) was adopted on July 4, 2012. Pursuant to this law, the State Administration of Medicinal Products developed the Import Licensing Conditions (―Conditions‖) (established by MoH Order No. 453 dated May 30, 2013), which became effective on December 1, 2013.Ostensibly, the Conditions were imposed to implement similar standards to those in the EU, but fail to take into account differences between the EU and the Ukraine in terms of importation systems, laboratory capacity and distribution models. Following an intensive dialogue with the State Administration on Medicinal Products between July and November 2013, amendments to the Import Licensing Conditions were adopted at the end of last year (MoH Order No. 960, November, 8, 2013) that postpone some of the less-defined aspects of the Conditions until March 2016. Nonetheless, given that local producers will not have to obtain a similar license (and the history of favoring local production), PhRMA members are strongly concerned that any developments with these regulations need to be monitored to ensure that they do not discriminate against foreign producers of medicines.
Transparent Legislative Environment and Predictable Regulatory Policy
Greater legislative transparency and a predictable regulatory environment are necessary factors if the Government‘s reform agenda is to be successful. PhRMA and its member companies are ready to share best international and European practices related to healthcare reform broadly, and government pricing and reimbursement of pharmaceuticals in particular. Unfortunately, many of the measures discussed above were adopted without ample engagement with stakeholders, including PhRMA member.Damage Estimate
At the time of reporting PhRMA is not able to provide a specific estimate of the damages incurred in 2013 attributable to trade barriers related to intellectual property protection and market access.Source: PHARMACEUTICAL RESEARCH ANDMANUFACTURERS OF AMERICA(PhRMA)SPECIAL 301 SUBMISSION 2014
Leave a Comment